ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE, MODEL LD-100

K092245 · Honsun (Nantong) Co., Ltd. · DXQ · Oct 28, 2009 · Cardiovascular

Device Facts

• Record ID: K092245
• Device Name: ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE, MODEL LD-100
• Applicant: Honsun (Nantong) Co., Ltd.
• Product Code: DXQ · Cardiovascular
• Decision Date: Oct 28, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1120
• Device Class: Class 2

Intended Use

The Aneroid Sphygmomanometer with Stethoscope is a non-automated, mechanical blood pressure monitor that is used for the indirect measurement (non-invasive) and display of arterial blood pressure. It can be used by professionals as well as trained individual users over age 18 at hospitals or at home. The device is for use in OTC.

Device Story

Non-automated, mechanical blood pressure monitor; consists of an occluding cuff, an aneroid gauge (300 mmHg), and a stethoscope. User inflates cuff manually; places stethoscope over brachial artery to detect Korotkoff sounds. Systolic and diastolic pressures are determined by auscultation. Used by clinicians or trained individuals in hospitals or home settings. Provides blood pressure readings to assist in monitoring arterial health.

Clinical Evidence

Bench testing only. Conformance to AAMI/ANSI SP10:2002/A2:2006 standard for non-automated sphygmomanometers.

Technological Characteristics

Non-automated, mechanical aneroid sphygmomanometer. Includes adjustable D-ring cuff, stethoscope, and 300 mmHg non-stop rotary pin gauge. Operates via manual inflation and auscultatory detection of Korotkoff sounds. Conforms to AAMI/ANSI SP10:2002/A2:2006.

Indications for Use

Indicated for non-invasive, indirect measurement and display of arterial blood pressure in individuals over age 18. Suitable for use by healthcare professionals and trained individuals in clinical or home settings.

Regulatory Classification

Identification

A blood pressure cuff is a device that has an inflatable bladder in an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The cuff is used in conjunction with another device to determine a subject's blood pressure.

Predicate Devices

• Aneroid Sphygmomanometer with Stethoscope (K060871)

Submission Summary (Full Text)

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# APPENDIX #1

HONSUN(NANTONG)CO.,LTD

## 510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in This summary of Shots) Sales) and the first & SMDA 1990 and 21 CFR §807.92.

The assigned 5l0(k) number is:

OCT 2 8 2009

### Submitter's Identification: 1. Company: HONSUN(NANTONG)CO.,LTD

Add: Add: No8, Tongxing Road, Nantong Economic & Technological Development Area JIANGSU CHINA E-mail: [e-mail]

Contact: Mr. David Zheng

Date Summary Prepared: 7TH June 2009

#### Trade or Proprietary Device Name: 2

Aneroid Sphygmomanometer with Stethoscope, Model LD-100

### Common or Usual Name:

Blood Pressure Kit (Blood Pressure Cuff)

### Classification Name:

Cuff, Blood Pressure

Panel: Cardiovascular

#### Legally Marketed Predicate Device: 3.

Aneroid Sphygmomanometer with Stethoscope, k060871 WENZHOU LONGWAN

# MEDICAL INSTRUMENT COMPANY

#### Device Description: 4.

The Aneroid Sphygmomanometer with Stethoscope is a non-invasive blood pressure The Anerold Spriygmomanomotor with on pressure levels. This Non-automated Sphygmomanometer uses an occluding cuff, an aneroid

### Page 1 of 2

Add: No8, Tongxing Road, Nantong Economic & Technological Development Area JIANGSU CHINA Tel:[phone]- + 614 Fax:[phone]

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Add: No8, Tongxing Road, Nantong Economic & Technological Development Area JIANGSU CHINA

Sphygmomanometer to measure pressure and a stethoscope for detecting Korotkoff sounds.

The Aneroid Sphygmomanometer with Stethoscope contains:

- Adjustable D-ring Cuff (Adult Size) 1.
- Stethoscope (Attaches to the cuff) 2.
- Non-stop rotary pin, 300 mmHg gauge 3.
- Instruction booklet and record ব
- Carrying case ട്.

The Aneroid Sphygmomanometer with Stethoscope enables the user to monitor The Arterold Sphygmomonomoter within the arteries at highest (systolic the procedio on and lowest (diastolic or relaxation) pressure.

To operate, the user places the attached stethoscope on the inner arm above the To operate, the user places the attached the brachial artery. After inflation of the cuff, berid in the elbow, to detect the pace of instethoscope to evaluate systelic and trie user does adultory moniteling was are usually recorded as a ratio of the two measurements: systolic over diastolic.

#### Intended Use: റ്റ്

The Aneroid Sphygmomanometer with Stethoscope is a non-automated, The Anefold Ophygmomanomettor that is used for the indirect measurement (non-invasive) and display of arterial blood pressure. It can be used by (nor-invasive) and display of archarblood procourer age 18 at hospitals or at home professionals as well as trainounting pressure. The device is for use in OTC.

Statement of Compliance to FDA Recognized Consensus Standards: ે.

The Aneroid Sphygmomanometer with Stethoscope, Model LD-100, has been The Ancroid Ophygmomananesi/AAMI AAMI / ANSI SP10:2002/A2:2006 Standard for Non-automated Sphygmomanometers.

- Conclusion: 7.
HONSUN(NANTONG)CO.,LTD. concludes that the subject Aneroid Sphygmomanometer with Stethoscope, Model LD-100, is as safe and effective as Sphygmomanometer with stomosopperer with Stethoscope, based on the predicate, Ancroid Ophygimsmar: 2006, "Standard for Manual, conformance to AAM17 ANOF OF 10.2002/1212000/ Studis as well as non-clinical mechanical testing performed.

Page 2 of 2

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

OCT 2 8 2009

Honsun (Nantong) Co., Ltd. c/o Mr. David Zhang Official Correspondent No8, Tongxing Road Nantong Economic & Technological Development Area Nantong, Jiangsu 226000 CHINA

K092245 Re:

> Trade/Device Name: Aneroid Sphygmomanometer with Stethoscope, Model LD-100 Regulatory Number: 21 CFR 870.1120 Regulation Name: Blood Pressure Cuff Regulatory Class: II (two) Product Code: DXQ Dated: September 15, 2009 Received: October 1, 2009

Dear Mr. Zhang:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. David Zhang

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807,97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Exhibit B

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510(k) Number (if known):

# Device Name: Aneroid Sphygmomanometer with Stethoscope Model LD-100

Indications For Use:

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| Prescription Use | |
|----------------------------|--|
| (Per 21 CFR 801 Subpart D) | |

Over-The Counter Use_x (21 CFR 807 Subpart C)

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number_

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Concurrence of CDRH, Office of Device Evaluation (ODE)

KO42245